StrokeNCT04984239
Adapting Acceptance and Commitment Therapy for Stroke Survivors With Aphasia
A study testing Acceptance and Commitment Therapy for aphasia in people with Stroke and Aphasia, run by University of Pittsburgh at 1 site in United States.
Trial summary
The proposed study is a Stage I successive cohort trial intended to adapt Acceptance and Commitment Therapy (ACT) to meet the specific needs of stroke survivors with aphasia ("ACT for Aphasia"). It will do so by incorporating communication supports and compensatory speech-language treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Acceptance and Commitment Therapy for aphasia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2021to 22 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants will be age 18 or older.
- Participants will have an existing diagnosis of aphasia subsequent to left hemisphere stroke.
Who cannot join
- Participants with a history of other acquired or progressive neurological disease.
- Participants whose mean modality t-score falls below 40 on the spoken language comprehension subdomain of the Comprehensive Aphasia Test.
- Participants with semantic memory impairments as determined by the cutoff of the semantic memory component of the Comprehensive Aphasia Test.
- Participants with unmanaged drug /alcohol dependence.
- Participants with severe diagnose.d mood or behavioral disorders that require specialized mental health interventions
Trial locations and contacts
1 site in 1 country.
United States1 site
Language Rehab and Cognition Lab, Department of Communication Sciences and Disorders, School of Health and Rehabilitation Sciences, University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Adapting Acceptance and Mindfulness-based Behavior Therapy for Stroke Survivors With Aphasia to Improve Communication Success, Post-stroke Adaptation, and Quality of Life
The proposed study is a Stage I successive cohort trial intended to adapt Acceptance and Commitment Therapy (ACT) to meet the specific needs of stroke survivors with aphasia ("ACT for Aphasia"). It will do so by incorporating communication supports and compensatory speech-language treatment. The goal of developing this integrated treatment is to improve successful communication participation, psychosocial adjustment, and quality of life for stroke survivors with aphasia.
In the first phase of the project, the investigators will create a treatment manual with input from a stakeholder advisory board consisting of caregivers and stroke survivors with aphasia. The investigators will then recruit an initial cohort of five stroke survivors with aphasia to undergo the initial version of the treatment based and provide feedback. This will aid revision of the manual, which the investigators will then evaluate using a second cohort of 16 stroke survivors with aphasia. The investigators predict that ACT for Aphasia will be acceptable and feasible based on measures of participant satisfaction and treatment adherence. The investigators will also measure pre- to post-treatment changes in psychological distress, functional disability, quality of life, and communication participation and functioning to establish preliminary effect size estimates for this intervention, in preparation for a subsequent Stage II efficacy trial.
Read the detailed description
The overarching goals of this research are to improve psychosocial adjustment, quality of life, and successful communication participation by developing Act for Aphasia, a patient-centered, manualized behavioral intervention in Stage I research. Stroke survivors with aphasia will complete a 10-session intervention. In study Aim 1, the investigators will engage a Stakeholder Advisory Board (SAB) of people with aphasia (PWA) and caregivers to provide input to develop a treatment manual. The investigators will then use an iterative design process and two successive participant cohorts to refine the manual. Cohort 1 (N=5) will participate in the initial version of the treatment, then help inform its revision by being invited to join the SAB. Cohort 2 (N=16) will participate in the revised version. In Aim 2a the investigators will establish feasibility and acceptability of this intervention. In Aim 2b the investigators will estimate preliminary effect sizes for a subsequent Stage II efficacy trial.
Participant assignment: given the early phase of this research and the lack of control conditions or groups, there will be no random assignment. Participants will be enrolled in the study as they are referred and found to be eligible, with the first five participants being enrolled in the first study cohort during year 1 while the remainder of participants will be enrolled in the second cohort across years 1 and 2.
Intervention description: the ACT for Aphasia treatment manual will be a 10-session intervention created by modifying an existing ACT manual provided by Dr. Meyer. To meet the specific needs of stroke survivors with aphasia, ACT will be modified in two main ways. First, the intervention will include modified language and communication supports to address the unique communication challenges faced by people with aphasia that could impede engagement with ACT content. Multi-modality communication supports will be provided by the treating clinician (e.g., writing out key words to support verbal content, summarizing and providing repetitions, providing session summaries to review between sessions). Manual creation will follow existing practice recommendations for modifying counseling interventions for PWA (e.g., simplifying language and increasing use of visual metaphors) which will be reviewed by the SAB. Second, ACT will be further augmented via individualized language compensation training and a focus on identifying and addressing communication-based barriers to life participation. Language training will focus on active compensatory strategies such as self-cuing, use of alternative modalities (gesture, writing), and use of commonly available technology (e.g., smartphone dictionaries, text-to-speech). The details of this language compensation training will also be determined based on input from the SAB, and will be revised after reviewing performance and interview feedback from each successive cohort.
Intervention administration procedures: all aspects of the treatment protocol will be administered by Dr. Evans or a licensed speech-language pathologist on study staff who has received training in providing ACT. The intervention will consist of 10 weekly treatment sessions. Post-treatment interviews providing feedback for protocol revision will be administered by Dr. Evans within 2 weeks of study completion. Interviews will use a semi-structured, ethnographic interview approach and be video-recorded. These interviews will ask specific questions about the participant's experience and perspective regarding each functional domain of the intervention (i.e., the "Open Up," "Be Present," and "Do What Matters" components of ACT and the individualized language compensation training), and will be asked for suggestions and improvements about the specific content and techniques employed.
Note that the values tracker measure was formally removed from the outcome measures in the study protocol. The protocol was modified to administer the values tracker informally during the treatment phase to help clinicians monitor progress and to guide in-session treatment discussions about value-based goal setting.
- Being tested
- Acceptance and Commitment Therapy for aphasia
- Keywords
- Counseling, Therapeutics
- Medical subject headings
- Stroke, Aphasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment Therapy for aphasiaBehavioural
The intervention will consist of Acceptance and Commitment Therapy modified to meet the needs of stroke survivors with aphasia, combined with communication strategy training.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy adapted for aphasia | Other | There is only a single study arm, in which the adapted intervention will be developed using a successive cohort design. Receives: Behavioral: Acceptance and Commitment Therapy for aphasia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Scores on the Client Satisfaction Questionnaire - 8
The Client Satisfaction Questionnaire - 8 (CSQ-8) is a brief questionnaire demonstrated to provide "efficient, sensitive, and reasonably comprehensive" measures of patient satisfaction. It has 8 questions rated on a 4-point scale (summed scores range from 8 to 32). High scores indicate high satisfaction and low scores indicate low satisfaction. The CSQ-8 is the primary measure which will determine acceptability of the proposed pilot intervention.
Measured: Post-treatment (within one week of completing the treatment phase)
Secondary outcomes (7)
Mean Scores on the Acceptance and Action Questionnaire II
The Acceptance and Action Questionnaire II (ACQ-II) is a self-report measure of psychological flexibility, acceptance, and experiential avoidance. It has 7 items rated on a 7-point scale (summed scores range from 7 to 49). Higher total scores reflect less psychological flexibility, while lower total scores reflect more flexibility. The ACQ-II will evaluate changes in psychological flexibility, the hypothesized mechanism of action underlying ACT for aphasia.
Measured: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury
The Acceptance and Action Questionnaire - Acquired Brain Injury (ACQ-ABI) is a 15 item self-report measure adapted from the ACQ-II specifically for people with acquired brain injury based on a 5-point Likert scale ranging from 15-75 where higher scores indicate greater levels of acceptance. While the ACQ-II addresses psychological flexibility generally, the ACQ-ABI measures psychological flexibility relating specifically to the consequences of acquired brain injury and is therefore an informative addition. Similar to the ACQ-II, it will also evaluate changes in psychological flexibility, the hypothesized mechanism of action underlying ACT for aphasia.
Measured: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Kessler K6 Non-specific Distress Scale
The Kessler K6 is a brief, validated instrument that assesses non-specific psychological distress experienced over the past 30 days. It has 6 items rated on a 0 to 4-point scale (summed scores range from 0 to 24). Higher total scores reflect greater psychological distress.
Measured: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Stroke and Aphasia Quality of Life Scale
The Stroke and Aphasia Quality of Life Scale is a 39-item patient reported measure of qualify of life adapted specifically for people with aphasia from the stroke survivor quality of life scale.
Total Mean Score: 39 items scored on 1-5 scale Physical Sub-Domain Mean Score: 16 items scored on 1-5 scale Communication Sub-Domain Mean Score: 7 items scored on a 1-5 scale Psychosocial Sub-Domain Mean Score: 16 items scored on 1-5 scale
For the total score and each subdomain score, values are determined by adding the sum of items relevant to that score (all 39 items for the total mean score, 16 items for the Physical Sub-Domain Mean Score, 7 items for the Communication Sub-Domain Mean Score, 16 items for the Psychosocial Sub-Domain Mean Score), then dividing by the number of relevant items for that score. In each case, the resulting maximum score of 5 and a minimum score of 1, with higher scores indicating higher quality of life.
Measured: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Aphasia Outcome Measure
The Aphasia Communication Outcome Measure (ACOM) is a measure of patient-reported "communication functioning," defined as the ability to effectively convey and receive personally relevant messages in natural environments. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication functioning.
Measured: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Communication Participation Item Bank
The Communication Participation Item Bank (CPIB) is a patient-reported measure of "communication participation" defined as "taking part in life situations where knowledge, information, ideas or feelings are exchanged." It has been validated for use with community-dwelling adults with multiple different communication disorders, including aphasia. Results are provided in T scores (sample mean of 50 with a standard deviations of 10), with higher scores indicating better communication participation.
Measured: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on Modified University of Washington Resilience Scale
The UWRS is a patient-reported outcome measure intended to measure an individual's perceived resilience. The original UWRS has been modified for people with aphasia (mUWRS), and was added to the study protocol for the second cohort of study participants to measure resilience pre- and post-treatment.
This measure is reported as a T-score with a mean of 50 and a standard deviation (SD) of 10. A higher T-score represents a higher level of resilience.
Measured: Baseline and Post-Treatment (within one week of completing the treatment phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start2 Nov 2021
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Delaware, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, William Evans, University of Pittsburgh
- Investigators
- William Evans, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984239
- Sponsor's protocol ID
- STUDY20090213
- Other IDs
- R03HD104246-01
- Status last verified
- Apr 2025
- First submitted
- 20 Jul 2021
- Last updated
- 25 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data from this research will be shared with the wider scientific community in a timely fashion, concurrent with publication with no planned end date. Materials shared in this fashion will consist of all de-identified participant assessment and outcome data, acceptability and feasibility measures, the study protocol, statistical analysis plan, and treatment manual. These materials will be shared via the National Institute of Child Health and Human Development Data and Specimen Hub (NICHD DASH) and made additionally available by sharing the developed treatment manual and other supporting information on Dr. Evans' lab website.
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting Acceptance and Mindfulness-based Behavior Therapy for Stroke Survivors With Aphasia to Improve Communication Success, Post-stroke Adaptation, and Quality of Life
- ClinicalTrials.gov ID
- NCT04984239
- Acronym / sponsor ID
- STUDY20090213
- Keywords
- Counseling, Therapeutics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Delaware, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 2 Nov 2021 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 30 Jul 2021 (actual)
- Results
- Posted 25 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study is a Stage I successive cohort trial intended to adapt Acceptance and Commitment Therapy (ACT) to meet the specific needs of stroke survivors with aphasia ("ACT for Aphasia"). It will do so by incorporating communication supports and compensatory speech-language treatment. The goal of developing this integrated treatment is to improve successful communication participation, psychosocial adjustment, and quality of life for stroke survivors with aphasia.
In the first phase of the project, the investigators will create a treatment manual with input from a stakeholder advisory board consisting of caregivers and stroke survivors with aphasia. The investigators will then recruit an initial cohort of five stroke survivors with aphasia to undergo the initial version of the treatment based and provide feedback. This will aid revision of the manual, which the investigators will then evaluate using a second cohort of 16 stroke survivors with aphasia. The investigators predict that ACT for Aphasia will be acceptable and feasible based on measures of participant satisfaction and treatment adherence. The investigators will also measure pre- to post-treatment changes in psychological distress, functional disability, quality of life, and communication participation and functioning to establish preliminary effect size estimates for this intervention, in preparation for a subsequent Stage II efficacy trial.
Detailed description
The overarching goals of this research are to improve psychosocial adjustment, quality of life, and successful communication participation by developing Act for Aphasia, a patient-centered, manualized behavioral intervention in Stage I research. Stroke survivors with aphasia will complete a 10-session intervention. In study Aim 1, the investigators will engage a Stakeholder Advisory Board (SAB) of people with aphasia (PWA) and caregivers to provide input to develop a treatment manual. The investigators will then use an iterative design process and two successive participant cohorts to refine the manual. Cohort 1 (N=5) will participate in the initial version of the treatment, then help inform its revision by being invited to join the SAB. Cohort 2 (N=16) will participate in the revised version. In Aim 2a the investigators will establish feasibility and acceptability of this intervention. In Aim 2b the investigators will estimate preliminary effect sizes for a subsequent Stage II efficacy trial.
Participant assignment: given the early phase of this research and the lack of control conditions or groups, there will be no random assignment. Participants will be enrolled in the study as they are referred and found to be eligible, with the first five participants being enrolled in the first study cohort during year 1 while the remainder of participants will be enrolled in the second cohort across years 1 and 2.
Intervention description: the ACT for Aphasia treatment manual will be a 10-session intervention created by modifying an existing ACT manual provided by Dr. Meyer. To meet the specific needs of stroke survivors with aphasia, ACT will be modified in two main ways. First, the intervention will include modified language and communication supports to address the unique communication challenges faced by people with aphasia that could impede engagement with ACT content. Multi-modality communication supports will be provided by the treating clinician (e.g., writing out key words to support verbal content, summarizing and providing repetitions, providing session summaries to review between sessions). Manual creation will follow existing practice recommendations for modifying counseling interventions for PWA (e.g., simplifying language and increasing use of visual metaphors) which will be reviewed by the SAB. Second, ACT will be further augmented via individualized language compensation training and a focus on identifying and addressing communication-based barriers to life participation. Language training will focus on active compensatory strategies such as self-cuing, use of alternative modalities (gesture, writing), and use of commonly available technology (e.g., smartphone dictionaries, text-to-speech). The details of this language compensation training will also be determined based on input from the SAB, and will be revised after reviewing performance and interview feedback from each successive cohort.
Intervention administration procedures: all aspects of the treatment protocol will be administered by Dr. Evans or a licensed speech-language pathologist on study staff who has received training in providing ACT. The intervention will consist of 10 weekly treatment sessions. Post-treatment interviews providing feedback for protocol revision will be administered by Dr. Evans within 2 weeks of study completion. Interviews will use a semi-structured, ethnographic interview approach and be video-recorded. These interviews will ask specific questions about the participant's experience and perspective regarding each functional domain of the intervention (i.e., the "Open Up," "Be Present," and "Do What Matters" components of ACT and the individualized language compensation training), and will be asked for suggestions and improvements about the specific content and techniques employed.
Note that the values tracker measure was formally removed from the outcome measures in the study protocol. The protocol was modified to administer the values tracker informally during the treatment phase to help clinicians monitor progress and to guide in-session treatment discussions about value-based goal setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy adapted for aphasia | Other | Behavioral: Acceptance and Commitment Therapy for aphasiaThere is only a single study arm, in which the adapted intervention will be developed using a successive cohort design. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants will be age 18 or older.
- Participants will have an existing diagnosis of aphasia subsequent to left hemisphere stroke.
Key exclusion criteria (5 listed)
- Participants with a history of other acquired or progressive neurological disease.
- Participants whose mean modality t-score falls below 40 on the spoken language comprehension subdomain of the Comprehensive Aphasia Test.
- Participants with semantic memory impairments as determined by the cutoff of the semantic memory component of the Comprehensive Aphasia Test.
- Participants with unmanaged drug /alcohol dependence.
- Participants with severe diagnose.d mood or behavioral disorders that require specialized mental health interventions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and Commitment Therapy for aphasiaThe intervention will consist of Acceptance and Commitment Therapy modified to meet the needs of stroke survivors with aphasia, combined with communication strategy training. | Behavioural | Acceptance and Commitment Therapy adapted for aphasia |
Primary outcome
Mean Scores on the Client Satisfaction Questionnaire - 8
Time frame: Post-treatment (within one week of completing the treatment phase)
The Client Satisfaction Questionnaire - 8 (CSQ-8) is a brief questionnaire demonstrated to provide "efficient, sensitive, and reasonably comprehensive" measures of patient satisfaction. It has 8 questions rated on a 4-point scale (summed scores range from 8 to 32). High scores indicate high satisfaction and low scores indicate low satisfaction. The CSQ-8 is the primary measure which will determine acceptability of the proposed pilot intervention.
7 secondary outcomes
Mean Scores on the Acceptance and Action Questionnaire II
Time frame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Acceptance and Action Questionnaire - Acquired Brain Injury
Time frame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Kessler K6 Non-specific Distress Scale
Time frame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Stroke and Aphasia Quality of Life Scale
Time frame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Aphasia Outcome Measure
Time frame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on the Communication Participation Item Bank
Time frame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Mean Scores on Modified University of Washington Resilience Scale
Time frame: Baseline and Post-Treatment (within one week of completing the treatment phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data from this research will be shared with the wider scientific community in a timely fashion, concurrent with publication with no planned end date. Materials shared in this fashion will consist of all de-identified participant assessment and outcome data, acceptability and feasibility measures, the study protocol, statistical analysis plan, and treatment manual. These materials will be shared via the National Institute of Child Health and Human Development Data and Specimen Hub (NICHD DASH) and made additionally available by sharing the developed treatment manual and other supporting information on Dr. Evans' lab website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Evans, PhD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy for aphasia in people with Stroke and Aphasia, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Scores on the Client Satisfaction Questionnaire - 8 (time frame: Post-treatment (within one week of completing the treatment phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.